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QC Analyst

R&D Partners

MunsterFull-timeMid LevelOn-site

Job Description

Ensure quality at every step-driving compliant, high-impact lab operations in a cutting-edge pharmaceutical environment.

R&D Partners is seeking a QC Analyst to join a leading pharmaceutical company in ROI. This role involves supporting laboratory setup activities, performing quality control testing, and ensuring compliance with cGMP and regulatory standards. The ideal candidate will have a strong background in analytical methods, laboratory operations, and quality assurance.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities

  • Support laboratory setup activities at the Cashel site.
  • Prepare laboratory procedures, specifications, protocols, and reports.
  • Perform laboratory testing and investigations per SOPs and cGMP requirements.
  • Conduct peer reviews of documentation as needed.
  • Execute analytical method verification, validation, and technical transfer.
  • Manage laboratory consumables, including ordering and tracking.
  • Assist in equipment qualification activities.
  • Collaborate with other departments and support laboratory colleagues daily.
  • Liaise with CROs on behalf of the company and conduct audits when appropriate.
  • Ensure audit readiness and support preparation for regulatory audits/visits.
  • Develop QC testing processes and maintain compliance with EHS governance.
  • Operate in compliance with global policies, procedures, and regulatory requirements.
  • Maintain a clean and organized work area to ensure product security.
  • Perform analytical balance calibrations and other tasks as defined in relevant SOPs.

Key Skills and Requirements

  • Strong understanding of cGMP and regulatory compliance.
  • Experience in analytical method validation and technical transfer.
  • Familiarity with laboratory setup and equipment qualification.
  • Excellent documentation and Good Documentation Practice (GDP) skills.
  • Ability to collaborate across departments and support cross‑functional teams.
  • Strong organizational and problem‑solving skills.
  • Prior experience in a pharmaceutical or biopharmaceutical environment is preferred.

For more information, please contact Jessica Taylor.

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